(Under forberedelse) Kommisjonens gjennomføringsforordning (EU) .../... om fastsettelse av regler for anvendelse av forordning (EU) 2021/2282 med hensyn til framgangsmåter for felles vitenskapelige veiledning på legemidler for mennesker på unionsnivå
Europeisk samarbeid om medisinske metodevurderinger: utfyllende bestemmelser om felles veiledning
(In preparation) Commission Implementing Regulation (EU) .../... laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medicinal products for human use at Union level
Utkast til forordning lagt fram av Kommisjonen 1.10.2024 med tilbakemeldingsfrist 29.10.2024
Nærmere omtale
BAKGRUNN (fra Kommisjonens initiativ 1.10.2024)
Health technology assessment – Joint scientific consultations on medicinal products for human use
EU rules on health technology assessment (Regulation 2021/2282) support cooperation by EU countries to clinically assess new health technologies. The aim is to contribute to a good use of health system resources, while respecting national competences. This initiative concerns joint scientific consultations on medicines. It sets out implementing rules detailing how developers can receive early guidance on the evidence and data needed to carry out a joint clinical assessment of their product.
Draft act
Feedback period: 01 October 2024 - 29 October 2024
Draft implementing regulation - Ares(2024)6931211